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FDA Given Two Years to Finalize Changes to Food Safety Regulations

Thursday, June 27, 2013

Sandler, Travis & Rosenberg Trade Report

The U.S. District Court for the Northern District of California has ordered the Food and Drug Administration to conclude the process of proposing regulatory changes required by the Food Safety Modernization Act by Nov. 30. Final rules will then have to be issued no later than June 30, 2015.

The FDA had proposed a series of “target timeframes” for issuing the proposed and final rules that would have seen the last of the regulations issued as late as spring 2016. The court rejected this approach as contrary to the intent of Congress that the FSMA rulemaking process be “closed-ended, rather than open-ended.”

On the other hand, the court said, the task of formulating the “major modifications” needed to implement the most sweeping overhaul of U.S. food safety laws in 70 years is a complex one, and the FDA has been diligent in attempting to meet this responsibility. The court therefore determined that the May 1, 2014, deadline for all regulatory changes proposed by the Center for Food Safety, which brought the underlying court case in an effort to speed the issuance of the FSMA rules, is “overly restrictive.” The court also rejected CFS’ request that the FDA be required to submit quarterly reports on the progress of the regulatory changes because it would be a strain on the agency’s already limited resources.

Earlier this year the FDA issued its first two proposed rules to implement FSMA provisions, one on procedures to ensure safe produce and the other requiring domestic and foreign food facilities to establish plans to identify and respond to food safety hazards. Other proposed regulatory changes have yet to be published, including rules on the Foreign Supplier Verification Program, sanitary transportation of food products, accreditation of third parties to conduct audits of foreign food facilities, and protection against intentional adulteration.